Label: SKIN IRRITATIONS AND ITCH RELIEF- arsenicum album, agaricus muscarius, alumina, anagallis arvensis, antimonium tartaricum, apis mellifica, arsenicum lodatum, bovista, causticum, dolichos pruriens, fagopyrum esculentum, graphites, kali muriaticum, muriaticum acidum, oleander, petroleum, pix liquida, radium bromatum, rhus toxicodendron, selenium metallicum, sulphur, urtica urens liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated February 27, 2015

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Drug Facts​__________________________________________________________________________________________________________

    HPUS active ingredients: Arsenicum album, ​Agaricus muscarius, Alumina, Anagallis arvensis, Antimonium tartaricum, Apis mellifica, Arsenicum lodatum, Bovista, Causticum, Dolichos pruriens, Fagopyrum esculentum, Graphites, Kali muriaticum, Muriaticum acidum, Oleander, Petroleum, Pix liquida, Radium bromatum (12X, 30X,100X,1M,LM1,LM2, LM3), Rhus toxicodendron, Selenium metallicum, Sulphur, Urtica urens. Equal volumes of each ingredient in 10X, 30X, 100X, 1M, LM1, LM2, LM3 potencies, unless otherwise noted.

  • INDICATIONS & USAGE

    Uses for temporary relief of irritations and itching from: rashes, hives, and red, burning, sensitive, dry, rough, scaly or chapped skin.

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Bio-Energetically Enhanced™ pure water, citric acid and potassium sorbate.

  • WARNINGS

    Warnings

    • Stop use and ask your doctor if symptoms persist or worsen.
    • If pregnant or breast-feeding, take only on advice of a healthcare professional.
  • KEEP OUT OF REACH OF CHILDREN

    • Keep out of reach of children.
  • DOSAGE & ADMINISTRATION

    Directions

    • Initially, depress pump until primed.
    • Spray one dose directly into mouth.
    • Adults 12 and up: 3 sprays 3 times per day
    • Children 2-12: 2 sprays 3 times per day
    • Children 2mo-2yr: 1 spray 3 times per day
  • OTHER SAFETY INFORMATION

    Tamper resistant for your protection. Use only if safety seal is intact. This product has not been clinically tested.

  • PURPOSE

    Uses ​for temporary relief of irritations and itching from: rashes, hives, and red, burning, sensitive, dry, rough, scaly or chapped skin.

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    SKIN IRRITATIONS AND ITCH RELIEF 
    arsenicum album, agaricus muscarius, alumina, anagallis arvensis, antimonium tartaricum, apis mellifica, arsenicum lodatum, bovista, causticum, dolichos pruriens, fagopyrum esculentum, graphites, kali muriaticum, muriaticum acidum, oleander, petroleum, pix liquida, radium bromatum, rhus toxicodendron, selenium metallicum, sulphur, urtica urens liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57955-0168
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE10 [hp_X]  in 59 mL
    AMANITA MUSCARIA FRUITING BODY (UNII: DIF093I037) (AMANITA MUSCARIA FRUITING BODY - UNII:DIF093I037) AMANITA MUSCARIA FRUITING BODY10 [hp_X]  in 59 mL
    ALUMINUM OXIDE (UNII: LMI26O6933) (ALUMINUM OXIDE - UNII:LMI26O6933) ALUMINUM OXIDE10 [hp_X]  in 59 mL
    ANAGALLIS ARVENSIS (UNII: 46883LR90E) (ANAGALLIS ARVENSIS - UNII:46883LR90E) ANAGALLIS ARVENSIS10 [hp_X]  in 59 mL
    ANTIMONY POTASSIUM TARTRATE (UNII: DL6OZ476V3) (ANTIMONY CATION (3+) - UNII:069647RPT5) ANTIMONY POTASSIUM TARTRATE10 [hp_X]  in 59 mL
    APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA10 [hp_X]  in 59 mL
    ARSENIC TRIIODIDE (UNII: 3029988O2T) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIIODIDE10 [hp_X]  in 59 mL
    LYCOPERDON UTRIFORME FRUITING BODY (UNII: K2A74U428F) (LYCOPERDON UTRIFORME FRUITING BODY - UNII:K2A74U428F) LYCOPERDON UTRIFORME FRUITING BODY10 [hp_X]  in 59 mL
    CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU) CAUSTICUM10 [hp_X]  in 59 mL
    MUCUNA PRURIENS FRUIT TRICHOME (UNII: 3E271BSI0C) (MUCUNA PRURIENS FRUIT TRICHOME - UNII:3E271BSI0C) MUCUNA PRURIENS FRUIT TRICHOME10 [hp_X]  in 59 mL
    FAGOPYRUM ESCULENTUM (UNII: B10M69172N) (FAGOPYRUM ESCULENTUM - UNII:B10M69172N) FAGOPYRUM ESCULENTUM10 [hp_X]  in 59 mL
    GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O) GRAPHITE10 [hp_X]  in 59 mL
    POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CATION10 [hp_X]  in 59 mL
    HYDROCHLORIC ACID (UNII: QTT17582CB) (HYDROCHLORIC ACID - UNII:QTT17582CB) HYDROCHLORIC ACID10 [hp_X]  in 59 mL
    NERIUM OLEANDER LEAF (UNII: 7KV510R6H6) (NERIUM OLEANDER LEAF - UNII:7KV510R6H6) NERIUM OLEANDER LEAF10 [hp_X]  in 59 mL
    KEROSENE (UNII: 1C89KKC04E) (KEROSENE - UNII:1C89KKC04E) KEROSENE10 [hp_X]  in 59 mL
    PINE TAR (UNII: YFH4WC535J) (PINE TAR - UNII:YFH4WC535J) PINE TAR10 [hp_X]  in 59 mL
    RADIUM BROMIDE (UNII: R74O7T8569) (RADIUM CATION - UNII:05456MVL7T) RADIUM BROMIDE12 [hp_X]  in 59 mL
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF10 [hp_X]  in 59 mL
    SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B) SELENIUM10 [hp_X]  in 59 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR10 [hp_X]  in 59 mL
    URTICA URENS (UNII: IHN2NQ5OF9) (URTICA URENS - UNII:IHN2NQ5OF9) URTICA URENS10 [hp_X]  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57955-0168-259 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/06/2012
    Labeler - King Bio Inc. (617901350)
    Registrant - King Bio Inc. (617901350)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc.617901350manufacture(57955-0168)